FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79705–79728 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2001
STANNAH POWER CHAIR, MODEL 201
K994083 · IPL
Stannah Power Chairs , Ltd.
Physical Medicine · 488d
Cleared Apr 03, 2001
WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)
K001892 · FXX
White Knight Healthcare, Inc.
General Hospital · 286d
Cleared Apr 03, 2001
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
K003613 · MOS
GE Medical Systems
Radiology · 132d
Cleared Apr 03, 2001
ULTRASOUND SCANNER TYPE 2102
K003986 · IYN
B & K Medical A/S
Radiology · 98d
Cleared Apr 03, 2001
MODEL 455GE PHASED ARRAY WRIST COIL
K010074 · MOS
Medical Advances, Inc.
Radiology · 84d
Cleared Apr 03, 2001
POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE
K010110 · LZA
Shen Wei (Usa), Inc.
General Hospital · 81d
Cleared Apr 03, 2001
THINKINGNET
K010271 · LLZ
Thinking Systems Corp.
Radiology · 64d
Cleared Apr 03, 2001
ADVIA RETIC PLUS
K010461 · JPK
R&D Systems, Inc.
Hematology · 46d
Cleared Apr 03, 2001
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
K010558 · MLE
Inova Diagnostics, Inc.
Immunology · 36d
Cleared Apr 03, 2001
MAMMOGRAPH
K010792 · IZH
Digitec Medical Service Corp.
Radiology · 18d
Cleared Apr 03, 2001
LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE)
K010860 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 12d
Cleared Apr 03, 2001
LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE)
K010861 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 12d
Cleared Apr 02, 2001
WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
K001893 · FXX
White Knight Healthcare, Inc.
General Hospital · 285d
Cleared Apr 02, 2001
WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)
K001997 · FXX
White Knight Healthcare, Inc.
General Hospital · 276d
Cleared Apr 02, 2001
AT3C70 TRANSDUCER
K002856 · ITX
Sonora Medical Systems
Radiology · 201d
Cleared Apr 02, 2001
CYNOSURE PHOTOGENICA DL
K010005 · GEX
Cynosure, Inc.
General & Plastic Surgery · 90d
Cleared Apr 02, 2001
VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 &...
K010010 · GEI
Valleylab, Inc.
General & Plastic Surgery · 90d
Cleared Apr 02, 2001
COUCH FOR TOTAL BODY RADIATION
K010063 · IYE
Arplay Medical S.A.
Radiology · 84d
Cleared Apr 02, 2001
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
K010092 · GWF
Excel Tech. , Ltd.
Neurology · 81d
Cleared Apr 02, 2001
BIPOLAR COAGULATION SYSTEM
K010112 · GEI
Enable Medical Corp.
General & Plastic Surgery · 80d
Cleared Apr 02, 2001
ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION
K010192 · GEI
Antyllos Medizintechnik GmbH
General & Plastic Surgery · 70d
Cleared Apr 02, 2001
FLEXIBLE ENDOSCOPIC SCISSORS
K010412 · OCZ
Telemed Systems, Inc.
Gastroenterology & Urology · 49d
Cleared Apr 02, 2001
MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM...
K010685 · HSX
Zimmer, Inc.
Orthopedic · 25d
Cleared Apr 02, 2001
PHILIPS BV LIBRA
K010762 · OXO
Philips Medical Systems, Inc.
Radiology · 19d